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Study of Sacituzumab Govitecan for Patients with Metastatic Solid Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called sacituzumab govitecan, also known by its code name IMMU-132, on patients with metastatic solid tumors. Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. The treatment being tested is a medication that is given through an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well sacituzumab govitecan works in treating these types of cancers. Participants in the study will receive the medication and will be monitored by healthcare professionals to assess their response to the treatment. The study will track the progress of the disease and any changes in the size of the tumors using specific criteria known as RECIST 1.1, which is a standard way to measure how well a cancer treatment is working.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study will also collect information on any side effects experienced by participants and how the body processes the medication. This information will help researchers understand the potential benefits and risks of using sacituzumab govitecan for treating metastatic solid tumors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to provide written informed consent. This consent indicates understanding and agreement to participate in the study.

    A baseline biopsy may be required if previous tissue samples are not available. This involves collecting a small sample of tissue for analysis.

  2. Step 2

    Screening and eligibility

    The patient will undergo a screening process to confirm eligibility. This includes meeting specific health criteria such as adequate blood counts and liver function.

    The patient must have a life expectancy of at least three months and measurable disease as determined by imaging tests like CT or MRI scans.

  3. Step 3

    Treatment administration

    The patient will receive the medication sacituzumab govitecan, also known as Trodelvy, which is administered as a solution for infusion through an intravenous route.

    The dosage and frequency of administration will be determined by the study protocol and the patient's specific condition.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient's response to the treatment will be monitored using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

    Regular assessments will be conducted to evaluate the objective response rate (ORR) and other health indicators.

  5. Step 5

    Completion of study

    The study is estimated to conclude by March 31, 2025. Upon completion, the patient's overall response to the treatment will be evaluated.

    The study will also assess the incidence of any treatment-related adverse events and the presence of anti-drug antibodies.

Who can join the trial?

14 criteria

  • Participants must be **female or male** and **over 18 years old**.
  • Participants must be able to **understand and give written consent** to join the study.
  • Participants need to provide **tumor samples** from a previous biopsy or surgery. If these are not available, a new biopsy is required.
  • Participants must have **metastatic or locally advanced solid tumors** that have progressed after specific treatments. This includes:
    • **NSCLC** (a type of lung cancer) that has worsened after certain chemotherapy and immunotherapy treatments.
    • **HNSCC** (a type of head and neck cancer) that has worsened after certain chemotherapy and immunotherapy treatments, with no more than three previous treatments.
    • **Endometrial carcinoma** (a type of uterine cancer) that has worsened after certain chemotherapy and immunotherapy treatments, with no more than three previous treatments.
    • **Extensive stage SCLC** (a type of lung cancer) that has worsened after certain chemotherapy and immunotherapy treatments, with no more than one previous treatment.
    • Participants must have an **ECOG Performance Status** score of 0 or 1, which indicates they are fully active or have some restrictions but can still do light work.
    • Participants must have **adequate blood counts** without needing recent blood transfusions or growth factor support.
    • Participants must have **adequate liver function**, meaning certain liver tests must be within acceptable limits.
    • Participants must have a **creatinine clearance** of at least 30 mL/min, which is a measure of kidney function.
    • Participants must have a **life expectancy of at least 3 months**.
    • Participants must have **measurable disease** as shown by a CT or MRI scan.
    • Male and female participants who can have children and engage in heterosexual intercourse must agree to use **specified methods of contraception**.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than the one being studied, which is **metastatic solid tumors**. This means the cancer has spread from its original location to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group being studied, which may include certain health conditions or characteristics.
  • Patients who are considered part of a **vulnerable population**. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Sacituzumab Govitecan is a medication being studied for its effectiveness in treating metastatic solid tumors. It is designed to target and deliver chemotherapy directly to cancer cells, potentially reducing the growth and spread of tumors. This study aims to evaluate how well this medication works in shrinking tumors in patients with advanced cancer.

What is already known about the treatment

Sacituzumab Govitecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic solid tumors. It is an investigational drug, meaning it is still under research and not yet widely available in medical practice. Sacituzumab Govitecan is primarily indicated for patients with advanced cancers that have spread to other parts of the body. Its mechanism of action involves targeting a specific protein on cancer cells, delivering a toxic agent directly to these cells to inhibit their growth. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.

Investigated diseases

Metastatic Solid Tumors – These are cancers that have spread from their original site to other parts of the body. They can originate from various organs, such as the breast, lung, or colon, and then metastasize to areas like the liver, bones, or brain. The progression involves cancer cells breaking away from the primary tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs. This spread can lead to a range of symptoms depending on the location and size of the metastatic tumors. The disease can affect multiple systems in the body, leading to complex clinical presentations. The management of metastatic solid tumors often requires a multidisciplinary approach due to their widespread impact.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513611-28-00Protocol codeIMMU-132-11Estimated enrolment227 patientsSponsorGilead Sciences Inc.

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